MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 3 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 02-012-35-3011

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 03/14/2023

Event Type  Injury  

Manufacturer Narrative

D10: concomitant devices: 2584040 02-012-45-3020 - lgc tibial fit tray cem sz 3f / 2t.2830911 200-02-35 - three peg patella 35mm.2857570 02-010-01-0230 - logic femoral ps cem left sz 3.9y088 203-96-03 - (11-2216) saw blade new stryker (.050).9y090 203-96-01 - (11-2222) saw blade new stryk (.050).H3: the revision reported was likely the result of prosthesis wear of the tibial insert.The cause of prosthesis wear is generally a combination of risk factors including, use error, implant positioning, implant size selection, and patient factors.However, this cannot be conclusively determined with the information provided.

Event Description

As reported via legal documentation, a patient had a left total knee replacement procedure on (b)(6) 2013 and then was revised on (b)(6) 2023.The patient required revision surgery for issues including but not limited to significant pain in her left knee, along with swelling, instability, limited range of motion, and loss of mobility.The mostly likely cause for the revision reported due to prosthesis wear is a combination of risk factors including use error, implant positioning, implant size selection, and patient factors.However, this cannot be conclusively determined with the information provided.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 3 11MM
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: matt collins ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19191874
• MDR Text Key: 341148346
• Report Number: 1038671-2024-00990
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10885862001818
• UDI-Public: 10885862001818
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033883
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/19/2021
• Device Catalogue Number: 02-012-35-3011
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/04/2024
• Initial Date FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/22/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0021-2022
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention